BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Graft, Vascular, Synthetic/Biologic Composite

    PMA: P890045 · Decision Jan 11, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Graft, Vascular, Synthetic/Biologic Composite
    Trade Name
    GELSEAL TM TRIAXIAL VASCULAR GRAFT
    PMA Number
    P890045
    Device Class
    FDA Class 2
    Product Code
    MAL
    Generic Name
    GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    January 11, 1993
    Date Received
    August 21, 1989
    Expedited Review
    N
    Docket Number
    93M-0023

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAL Graft, Vascular, Synthetic/Biologic Composite